制霉菌素搽剂微生物限度检查方法探讨

Discussion on Microbial Limit Test of Nystatin Liniment

目的:建立制霉菌素搽剂的微生物限度检查方法。方法:根据2015年版《中国药典》方法,采用平皿法、薄膜过滤法联合中和剂对制霉菌素搽剂进行微生物限度检查方法探讨。结果:利用预热至45℃的聚山梨酯-80和卵磷脂的中和作用,制霉菌素搽剂需氧菌总数、霉菌和酵母菌总数采用薄膜过滤法联合中和剂的方法进行检查,控制菌的检查采用常规法,结果均符合2015年版《中国药典》的规定。结论:制霉菌素搽剂微生物限度计数方法综合采用薄膜过滤法、中和剂法(预热45℃)消除其对白色念珠菌的抗菌活性,使需氧菌、霉菌和酵母菌的回收结果符合药典要求。按2015年版《中国药典》方法对控制菌进行实验,控制菌检查可采用常规法进行。

Objective： To establish a method for microbial limit test of nystatin liniment. Methods： According to the Chinese Pharmacopoeia（ 2015 Edition）,the plate count method,membrane-filter method combined with neutralizing agent were adopted to conduct the microbial limit test on nystatin liniment. Results： The neutralization of polysorbate-80 and lecithin preheated at 45 ℃ were used,the total aerobic bacteria,mold and yeast of the nystatin liniment were examined by membrane-filter procedure combined with a neutralizer,the controlled bacteria were examined by conventional methods. All results of examinations were in line with the specifications of the Chinese Pharmacopoeia（ 2015 Edition）. Conclusion： The microbial limit counting method of nystatin tincture has combined membrane-filtration method with neutralizer method（ with preheating at 45 ℃） to eliminate the antibacterial activity against Candida albicans,so that the recovery results of aerobic bacteria,mold and yeast can meet the specifications of pharmacopoeia.According to the Chinese Pharmacopoeia（ 2015 Edition）,the control bacteria can be examined by conventional methods.